EHR-embedded OCDT in Breast or GI Cancer

Not Applicable

Completed

• Conditions: Oral Chemotherapy; Breast Cancer; Gastrointestinal Cancer; Oral Cancer Directed Therapy
• Interventions: Other: Active Care Team Alert; Other: Passive Care Team Alert

• Registration Number: NCT03858712
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

This is research study is for participants with advanced breast or gastrointestinal cancer who have been taking oral chemotherapy medication (Oral Cancer Directed Therapy). This study is to help researchers better understand gaps in assessing oral chemotherapy patient toxicity at home, adherence to treatment and integrate toxicity/adherence reporting.

Detailed Description

For patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy.

* Participants will complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice

* Participants between clinic visits, will be asked to complete the oral weekly survey at home via the mobile or web based patient portal. The survey can be completed on a computer, tablet or smartphone at home or on a tablet at the time of scheduled visit.

* The first 100 participants to complete the survey will receive a passive care team alert for responses (per DFHCC policy)

* The second 100 participants to complete the survey will receive an active care team alert for responses.

Study Timeline

• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-03-01
• Study Start: 2019-03-13
• Primary Completion: 2021-11-23
• Study Completion: 2021-11-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adult age 18 or older
• Male or Female
• Scheduled visit at DF/HCC within the BOC or GCC
• Diagnosis of advanced breast cancer or gastrointestinal cancer
• Prescribed any OCDT within prior 5 days of screening
• English as the primary language (as documented in the EHR, written or spoken, and patient interpreter needed flag = no)
• Mobile number listed in EHR to allow participation in ePP portion of the study
• Women of any pregnancy status
• Patients diagnosed with an advanced cancer will be eligible to participate in the study until discontinuation of OCDT or death, whichever occurs first

Exclusion Criteria

• Adults unable to provide verbal consent
• Pediatric patients
• Patients without access to a electronic device (including tablet, computer, aptop or smartphone)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Active Care Team Alert	Active Care Team Alert	DFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy. * Screening: ePRO Clinic:-- complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice * ePRO Home: -- ePRO oral between visits at home. * Active care team alert -- practice nurse monitoring of ePRO home responses score = 3 indicating a moderate-severe toxicity (grade 3 or higher
Passive Care Team Alert	Passive Care Team Alert	DFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy. * Screening: ePRO Clinic:-- complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice * ePRO Home: -- ePRO oral between visits at home. * Passive care team alert -- EHR inBasket notification

Primary Outcome Measures

Name	Time	Method
ePRO Oral Response Rate	30 days	proportion of participants responding to at least 50% of ePRO oral questionnaires at 30 days

Secondary Outcome Measures

Name	Time	Method
ePRO Oral Response Rate	90 days	proportion of participants responding to at least 50% of ePRO oral questionnaires at 90 days
Average number of ePRO oral questionnaires completed per week	90 Days	average number of ePRO oral questionnaires completed per week until discontinuation of OCDT or end of study (whichever occurs first)
ePRO oral ease of use	90 Days	Proportion of participants reporting that ePRO oral was either easy or very easy to use among participants who responded to at least one ePRO oral questionnaire
Proportion of Participants with an ePRO Intervention	90 Days	proportion of participants who were called by an office practice nurse for toxicity, had an OCDT dose modification, urgent clinic visit, ED visit or unplanned hospitalization among participants who responded to at least one ePRO oral questionnaire
Proportion of Participants reporting ePRO grade 3+ toxicity	90 Days	proportion of participants reporting grade 3+ toxicity on at least one ePRO oral questionnaire among participants who responded to at least one ePRO oral questionnaire
Participant Report of OCDT Frequency	30 Days	Among participant who self-reported missing ≥20%/\<20% of prescribed OCDT doses via ePRO oral, the proportion for whom EHR prescriptions also indicated non-adherence/adherence; EHR prescriptions measured by Proportion of Days Covered (PDC) = proportion of days covered by OCDT prescription claims divided by 30 days
ePRO oral willingness	90 Days	proportion of participants reporting that they were willing or very willing to use ePRO oral again in the future among participants who responded to at least one ePRO oral questionnaire

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States